Corona Virus Infection Clinical Trial
Official title:
Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
NCT number | NCT04412551 |
Other study ID # | LUS-Covid001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 20, 2020 |
Est. completion date | December 31, 2020 |
Verified date | May 2021 |
Source | Dalarna County Council, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Covid-19 confirmed by positive polymerase chain reaction (PCR) - oxygen by mask or nasal prongs = 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) = 30% - age between 18-80 years - informed consent Exclusion Criteria: - patients subject to treatment-limitation "no ICU" - history of heart failure - history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis - history of kidney failure requiring dialysis - any reason making lung ultrasound or daily follow up impossible - opposition to participation in the study |
Country | Name | City | State |
---|---|---|---|
Sweden | Falun Hospital | Falun |
Lead Sponsor | Collaborator |
---|---|
Dalarna County Council, Sweden |
Sweden,
Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of requirement of mechanical ventilation | Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU | 3 weeks | |
Secondary | Prediction of requirement of mechanical ventilation | Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU | 3 weeks | |
Secondary | Association of LUS to clinical parameters | Descriptive assessment of clinical parameters and LUS-score over time | 3 weeks | |
Secondary | Description of findings on LUS | Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19 | 3 weeks |
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